Custom-made Versus Prefabricated Zirconia Crowns for Primary Molars.

Decayed Teeth Clinical Trial

Official title:

Custom-made Versus Prefabricated Zirconia Crowns for Primary Molars; a Clinical Trial With 12-month Follow-up.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620174
• Other study ID #: PD-P-020-006
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Do construction methods of pediatric zirconia crowns affect the periodontal health and clinical performance of badly decayed primary molars? The question asked by many practitioners.

Purpose: to compare the periodontal health and clinical performance of primary molars restored with custom-made and prefabricated zirconia crowns. Hypothesis is the performance of primary molars restored with custom-made zirconia crowns will be equivalent to those restored with prefabricated zirconia crowns.

Description:

This study is a randomized, 12-month follow up clinical trial. According to sample size calculation, ten patients will be selected in conjunction with departments of Pedodontics and Crowns & Bridges. The study will be conducted in accordance with the principles of the Research Ethics Committee, Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt.

The purpose of the investigation and the clinical procedures of this study will be explained to the parents and children. A written informed consent form will be signed from patient guardians and obtained prior to study initiation. The inclusion and exclusion criteria are established as the following;

• Inclusion criteria

1. Children of 5-9 years old.

2. The children have at least 2 pulpotomized primary molars with no clinical signs & symptoms or periapical pathosis.

3. Presence of an intact contralateral primary molar as a control.

4. Willingness to participate and to continue with the follow up appointments.

5. Clinical and radiographically confirmed dental caries extending to the middle third of dentin.

6. Presence of teeth in opposite arch with normal occlusion.

• Exclusion criteria

1. Children with systemic health problem.

2. Children with periodontal disease.

3. Children with unilateral chewing habit or allergic to local anesthesia.

4. Presence of parafunctional habit.

• Clinical procedure;

1. Patient selection and education; The participating children will continue with their routine dental appointments in the undergraduate training clinic. Before beginning, children, along with their parents will receive a standard oral hygiene education by an undergraduate student through brushing demonstration on a model. Parents will be warned when signs of gingival inflammation are present, or plaque control is inadequate.

2. Samples grouping and teeth preparation:

Forty primary molars will be included in the study. Twenty decayed teeth will be restored with crowns (10 with custom-made ZrCs and 10 with prefabricated ZrCs), and the other twenty intact contralateral teeth will be evaluated as the controls (10 molars will be the controls for custom-made ZrCs and 10 molars will be the controls for prefabricated ZrCs). Preparation of the crowns will be performed under local anesthesia, according to manufacturers' instructions with the following guidelines; 1-2mm occlusal reduction, 0.5-1mm axial reduction, and a chamfer finish line will be established 0.5-1mm subgingivally.

3. Impression taking and temporization:

After preparation, rubber-base impressions will be taken for the teeth specific for custom-made ZrCs. Then SSCs will be temporarily cemented over the prepared teeth till the next appointment.

4. Try-in and cementation of ZrCs:

SSCs will be removed and the custom-made and prefabricated ZrCs will be tried in and permanently cemented.

• Follow-up visits:

The participants will be recalled for evaluation after a baseline and at 1, 3, 6 and 12 months.

• Evaluation methods:

1. The periodontal health will be assessed using the plaque index (PI) and the gingival index (GI).

2. The clinical success of the crowns will be assessed in terms of crown retention, marginal adaptation, crown contour, fracture, stain resistance, opposing tooth wear and tooth exfoliation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

Inclusion Criteria:

1. Children of 5-9 years old.

2. The children have at least 2 decayed primary molars.

3. Presence of an intact contralateral primary molar as a control.

4. Willingness to participate and to continue with the follow up appointments.

5. Clinical and radiographically confirmed dental caries extending to the middle third of dentin.

6. Presence of teeth in opposite arch with normal occlusion.

Exclusion Criteria:

1. Children with systemic health problem.

2. Children with periodontal disease.

3. Children with unilateral chewing habit or allergic to local anesthesia.

4. Presence of parafunctional habit.

Related Conditions & MeSH terms

• Decayed Teeth
• Dental Caries

Intervention

Other:
• Custom-made zirconia crowns
Ten decayed primary molars will be restored with custom-made zirconia crowns.
• Prefabricated zirconia crowns
Ten decayed primary molars will be restored with prefabricated zirconia crowns.

Locations

Country	Name	City	State
Egypt	Roqaia M Alassar	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in periodontal health.	The periodontal health will be assessed using the plaque index (PI) and the gingival index (GI)	At 1, 3, 6 and 12 months following application.
Secondary	Change in clinical performance.	The clinical success of the crowns will be assessed in terms of crown retention, marginal adaptation, crown contour, fracture, stain resistance, opposing tooth wear and tooth exfoliation.	At 1, 3, 6 and 12 months following application.